UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031224
Receipt number R000035660
Scientific Title A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol
Date of disclosure of the study information 2019/02/09
Last modified on 2019/02/13 09:19:30

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Basic information

Public title

A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol

Acronym

A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol

Scientific Title

A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol

Scientific Title:Acronym

A clinical study to evaluate the effects of beverage containing green tea catechins on reducing LDL cholesterol

Region

Japan


Condition

Condition

None

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effects of the intake of beverage containing green tea catechins for 12 weeks on reducing LDL cholesterol

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

LDL cholesterol

Key secondary outcomes

Total cholesterol, HDL cholesterol, LOX-index


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake of beverage containing green tea catechins for 12 weeks

Interventions/Control_2

Intake of placebo for 12 weeks

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Subjects whose age of 20 years or more and less than 65 years
2) Subjects whose serum LDL cholesterol levels are 120 mg/dL or more and less than 140 mg/dL (borderline) or 140 mg/dL or more and less than 160 mg/dL (mild Hypercholesterolemia) in the screening examination
3) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent

Key exclusion criteria

1) Subjects receiving a medical treatment for dyslipidemia
2) Subjects having serious hepatic, cardio-vascular, respiratory, endocrine or metabolic disorders
3) Subjects whose fasting serum triglyceride levels are 400 mg/dL or more
4) Subjects who have the possibility of developing allergic symptoms by the test food
5) Subjects who take Foods for Specified Health Uses or Foods with Function Claims labeled the effects of improving LDL cholesterol or total cholesterol levels
6) Subjects who take foods having the effects of improving LDL cholesterol or total cholesterol levels
7) Female subjects who are pregnant or lactating, or intending to be pregnant during the study
8) Female subjects who have menstrual irregularities
9) Subjects who have extremely irregular dietary habits, work in shifts or work during the night
10) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
11) Subjects who took part in another clinical study within 3 months prior to the start of the present study or who is currently taking part in another clinical study
12) Subjects deemed unsuitable by the investigator

Target sample size

140


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takanobu Takihara

Organization

ITO EN, Ltd.

Division name

Central Research Institute

Zip code


Address

21 Mekami, Makinohara, Shizuoka

TEL

0548-54-1247

Email

t-takihara@itoen.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Tomohiro Sugino

Organization

Soiken Inc.

Division name

Representative Director

Zip code


Address

Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka

TEL

06-6871-8888

Homepage URL


Email

sugino@soiken.com


Sponsor or person

Institute

Soiken Inc.

Institute

Department

Personal name



Funding Source

Organization

ITO EN, Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2019 Year 02 Month 09 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2017 Year 11 Month 18 Day

Date of IRB


Anticipated trial start date

2018 Year 02 Month 12 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 02 Month 09 Day

Last modified on

2019 Year 02 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035660


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name